MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 17GAL RED; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305610
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that an unspecified number of sharps coll 17gal red experienced the lid or slide lid/clamp missing.Product defect was noted prior to use.The following information was provided by the initial reporter: material no: 305610 batch no: 0044914.Customer says one of the cases is missing all the lids.Would like the lids sent out.
Additional Manufacturer Narrative
H.6.Investigation: the actual product nor photo representation was provided.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids during the manufacturing process of the reported lot.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.The root cause is unknown.The issue most likely occurred during fulfillment when repackaged for distribution.This complaint may have occurred from partial sales sold by a distributor.Additional information is needed about the handling and storage by the distributor facility to rule out that the issue was not due to incorrect handling or a partial sale.Based on these findings, our investigation is inconclusive.Evidence of original packaging is required.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified number of sharps coll 17gal red experienced the lid or slide lid/clamp missing.Product defect was noted prior to use.The following information was provided by the initial reporter: material no: 305610 batch no: 0044914 customer says one of the cases is missing all the lids.Would like the lids sent out.

• Brand Name: SHARPS COLL 17GAL RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10196825
• Report Number: 2243072-2020-00966
• Device Sequence Number: 2552637
• Product Code: FMI
• UDI-Device Identifier: 50382903056106
• UDI-Public: 50382903056106
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305610
• Device Lot Number: 0044914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other